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The packaging change which is the subject of this submission does not affect the intended uses of any of the commercially available UHMWPE components subject to the packaging change.

The components which contain UHMWPE as a bearing will be packaged in an inert environment. The packaging method will reduce the oxygen content within the package, thereby retarding oxidation.

The devices which are subject to the proposed packaging change are Osteonics implants which contain UHMWPE as a bearing. These devices all have their own, previously established 510(k) clearances. This 510(k) does not address any changes to any component or its device description; it addresses only a change to the way that the devices will be packaged.

As before, Osteonics' UHMWPE devices will continue to be packaged according to the previously featured "double blister" style method. However, in order to create an inert environment, the component packages will be flushed with Nitrogen and then vacuum sealed. This "N,/Vac" feature requires the following changes to the package itself:

Changes to Actual Package:

• 1. The current blister material is replaced with a less gas-permeable material.
• 2. The current lid stock is replaced with a less gas-permeable lid stock.
• 3. The inner/outer blister assembly will be placed within a pouch, adding another gas transmission barrier to the final package.

The proposed change in Osteonics' packaging does not affect the device sterility. The sealed inner and outer packaging blisters meet the same package and seal requirements as the traditional Osteonics' packaging. The radiation dose required for sterility is not affected by the new packaging materials, and the sterility assurance level (SAL) of 106 remains unchanged.

This 510(k) submission (K955944) is for a change in packaging for existing Osteonics' UHMWPE components, moving from standard room air packaging to a Nitrogen flush/vacuum sealing process. The goal of this change is to reduce oxygen content within the package, thereby retarding oxidation of the UHMWPE components.

Based on the provided document, there is no acceptance criteria or study that proves device performance in the context of an AI/ML device. This submission is for a packaging change for a physical medical device (UHMWPE components), not an AI-powered diagnostic or therapeutic tool. Therefore, the questions related to AI/ML device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable to this 510(k) summary.

The document primarily focuses on demonstrating that the new packaging method does not negatively impact the sterility or intended use of the previously cleared UHMWPE components. It achieves this by comparing the new packaging materials and process to existing packaging standards and methods used by other manufacturers.

Here's a breakdown of the relevant information provided, adapted to the context of a packaging change:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is for a packaging change, "device performance" in this context would relate to the packaging's ability to maintain an inert environment and sterility, and the UHMWPE components maintaining their characteristics. The document doesn't explicitly state numerical acceptance criteria in a table, but it implies the following:

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of data for an AI/ML device. The "test" in this context would likely involve physical testing of the packaging integrity, gas permeation, and sterility, which is not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of expert review for an AI/ML device. Decisions are based on material science and engineering principles related to packaging and sterilization.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device analysis. The "truth" here is established through material science testing, sterilization validation, and comparison to regulatory standards and predicate devices.

8. The sample size for the training set: Not applicable. There is no "training set."

9. How the ground truth for the training set was established: Not applicable. There is no "training set" or corresponding ground truth.

In summary, the provided document describes a regulatory submission for a packaging change, leveraging established principles of material science and sterilization, rather than presenting a performance study for an AI/ML diagnostic or therapeutic device.

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